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Heart Watch Study: protocol for a pragmatic randomised controlled trial
Sanket S Dhruva1,2, Nilay D Shah3,4, Sreekanth Vemulapalli5,6
1Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, California, USA sanket.dhruva@ucsf.edu.
BMJ Open
|March 2, 2022
Summary
This study investigates how Apple Watch features impact atrial fibrillation patients' quality of life and healthcare use after cardioversion. Results will inform patients and clinicians on wearable health technology effectiveness.
Area of Science:
- Cardiology
- Digital Health
- Health Services Research
Background:
- Personal digital devices, like the Apple Watch, offer advanced cardiopulmonary tracking features with regulatory clearance.
- Despite widespread use, limited data exists on the impact of these devices on patient-reported outcomes and healthcare utilization.
- Atrial fibrillation and flutter patients undergoing cardioversion represent a key population to study the effects of wearable health technology.
Purpose of the Study:
- To determine the impact of Apple Watch's heart rate, irregular rhythm notification, and ECG features on quality of life in patients undergoing cardioversion for atrial fibrillation/flutter.
- To assess the effect of these features on healthcare utilization (inpatient and outpatient) in the same patient population.
- To compare the accuracy of Apple Watch ECG and pulse oximeter data against gold-standard clinical measurements.
Main Methods:
- A prospective, open-label, multicentre pragmatic randomized clinical trial involving 150 patients undergoing cardioversion for atrial fibrillation or flutter.
- Participants are randomized 1:1 to receive either an Apple Watch Series 6 or a Withings Move at the time of cardioversion.
- The primary outcome is the change in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months post-cardioversion.
Main Results:
- The study is currently in progress, and results are pending.
- Data collection focuses on patient-reported quality of life and objective healthcare utilization metrics.
- Secondary analyses will compare wearable device data with clinical gold standards.
Conclusions:
- This trial will provide crucial data for policymakers, clinicians, and patients regarding the influence of widely adopted personal digital devices on patient well-being and healthcare resource use.
- Findings will be disseminated through participant updates, professional meetings, and peer-reviewed publications.
- The study addresses a significant knowledge gap concerning the real-world impact of consumer-grade health monitoring technology.
